A Two-stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel with Placebo in the Treatment of Female Participants with Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)
Latest Information Update: 23 Mar 2025
At a glance
- Drugs Iltamiocel (Primary)
- Indications Faecal incontinence
- Focus Registrational; Therapeutic Use
- Acronyms DigniFI
- Sponsors Cook MyoSite
Most Recent Events
- 14 Feb 2024 Planned initiation date changed from 1 Dec 2023 to 1 Feb 2024.
- 28 Nov 2023 Planned initiation date (estimated date for recruitment of the first subject) changed from 1 Sep 2023 to 1 Dec 2023.
- 28 Nov 2023 Status changed from not yet recruiting to recruiting.